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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceRevanesse® Lips+
Generic NameImplant, dermal, for aesthetic use
ApplicantProllenium Medical Technologies, Inc.
138 Industrial Pkwy. N.
Aurora L4G 4C3
PMA NumberP160042
Supplement NumberS010
Date Received09/30/2019
Decision Date09/21/2020
Product Code LMH 
Docket Number 20M-2021
Notice Date 09/29/2020
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT04032977
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Revanesse® Lips+. The device is indicated for submucosal implantation for lip augmentation in patients 22 years of age or older.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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